Handle extension for an elongate medical device

ABSTRACT

A medical device handle assembly can include a modular extension that allows for the addition of any number of connector ports to an existing handle. In an embodiment, such an extension can comprise a main body portion configured to be coupled with an elongate medical device shaft comprising at least one of an electrical wire and a fluid lumen. The main body portion may comprise a handle port configured to provide access to one or more of a fluid connector fluidly coupled with the fluid lumen and an electromechanical connector electrically coupled with the electrical wire. The handle assembly can further comprise a handle extension portion coupled with the handle port.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation-in-part of U.S. application Ser. No.13/487,569 (“the '569 application”), filed Jun. 4, 2012, now pending,and U.S. application Ser. No. 29/428,898 (“the '898 application”), filedAug. 3, 2012, now pending. The '569 application and the '898 applicationare hereby incorporated by reference in their entireties as though fullyset forth herein.

BACKGROUND OF THE INVENTION

a. Field of the Invention

This disclosure relates to elongate medical devices, such as, forexample and without limitation, catheters and sheaths or introducers.More particularly, this disclosure relates to modular handle extensiondevices for such elongate medical devices, and elongate medical devicesand components thereof that include such modular extension devices.

b. Background Art

It is known to use elongate medical devices, such as, for example,catheters and sheaths or introducers, when performing varioustherapeutic and/or diagnostic medical procedures on or in variousanatomical structures of a patient's body, such as, for example, theheart. Such devices generally include an elongate shaft having aproximal end portion, a distal end portion, a number of electrical andfluid elements, and a handle assembly disposed at the proximal endportion of the shaft. In order to provide access to the electrical andfluid elements in the shaft, the handle assembly generally includes oneor more connectors that can be coupled with fluid supplies, mapping andnavigation systems, and the like.

Known medical device handle assemblies are generally designed andconstructed with a particular shaft construction in mind—i.e., aparticular configuration of electrical elements, fluid elements,deflection mechanisms, and the like. If a new catheter shaft is designedand constructed, an entirely new handle typically must be designed andconstructed as well to accommodate the particular configuration of fluidelements, electrical elements, and other features of the catheter shaft.

The foregoing discussion is intended only to illustrate the presentfield and should not be taken as a disavowal of claim scope.

BRIEF SUMMARY OF THE INVENTION

In various embodiments, a medical device handle assembly may include amain body portion configured to be coupled with an elongate medicaldevice shaft comprising at least one of an electrical wire and a fluidlumen. The main body portion may comprise a handle port configured toprovide access to one or more of a fluid connector fluidly coupled withthe fluid lumen and an electromechanical connector electrically coupledwith the electrical wire. The handle assembly may further comprise ahandle extension portion coupled with the handle port.

Another embodiment of a handle assembly may include a main body portionconfigured to be coupled with a shaft and to receive one or more of anelectrical wire disposed at least partially in the shaft and a fluidlumen disposed at least partially in the shaft. The main body portionmay comprise a handle port configured to provide access to one or moreof an electromechanical connector electrically coupled to the electricalwire and a fluid connector fluidly coupled to the fluid lumen. Thehandle assembly may further include an extension portion configured tooccupy the handle port and including an extension port configured toreplicate the main body portion port.

An embodiment of a medical device can include a shaft comprising adistal end, a proximal end, and at least one of an electrical wire and afluid lumen. The medical device may further include a handle comprisinga main body portion and a handle extension portion. The handle main bodyportion may be coupled with the shaft proximal end and may comprise ahandle port configured to provide access to one or more of a fluidconnector fluidly coupled with the fluid lumen and an electromechanicalconnector electrically coupled with the electrical wire. The handleextension portion may be coupled with the handle port.

The foregoing and other aspects, features, details, utilities, andadvantages of the present invention will be apparent from reading thefollowing description and claims, and from reviewing the accompanyingdrawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a plan view of an exemplary elongate medical device inaccordance with the present teachings.

FIG. 2 is an exploded view of the exemplary elongate medical deviceillustrated in FIG. 1.

FIG. 3A is an isometric view of portions of the handle assembly anddeflection mechanism of the elongate medical device illustrated in FIGS.1 and 2 when the elongate medical device is in a neutral ornon-deflected state.

FIG. 3B is an isometric view of portions of the handle assembly anddeflection mechanism of the elongate medical device illustrated in FIGS.1 and 2 when the elongate medical device is in a deflected state.

FIG. 4 is an isometric view of the base member of an exemplary actuatorbody of the deflection mechanism illustrated in FIGS. 1-3B.

FIG. 5 is a plan view of a first face of the actuator body base memberillustrated in FIG. 4.

FIG. 6 is a cross-section view of an exemplary actuator of thedeflection mechanism illustrated in FIGS. 1 and 2 taken along line 6-6in FIG. 1.

FIGS. 7A and 7B are isometric views of portions of the elongate medicaldevice illustrated in FIG. 1 showing the distal end portion of the shaftof the elongate medical device deflected in different directions.

FIG. 8A is a side view of an exemplary embodiment of a wire lock of thedeflection mechanism illustrated in FIGS. 1 and 2.

FIG. 8B is a cross-section view of the wire lock illustrated in FIG. 8Ataken along the line 8B-8B in FIG. 8A.

FIG. 9A is an isometric view of an exemplary embodiment of a modularhandle extension of the handle illustrated in FIGS. 1 and 2.

FIGS. 9B and 9C are plan views of a first portion and a second portionof the modular handle extension illustrated in FIG. 9A.

FIGS. 9D-9G are diagrammatic plan views of alternate embodiments of asecond portion of a modular handle extension.

DETAILED DESCRIPTION OF EMBODIMENTS OF THE INVENTION

Various embodiments are described herein of various apparatus and/orsystems. Numerous specific details are set forth to provide a thoroughunderstanding of the overall structure, function, manufacture, and/oruse of the embodiments as described in the specification and illustratedin the accompanying drawings. It will be understood by those skilled inthe art, however, that the embodiments may be practiced without suchspecific details. In other instances, well-known operations, components,and elements have not been described in detail so as not to obscure theembodiments described in the specification. Those of ordinary skill inthe art will understand that the embodiments described and illustratedherein are non-limiting examples, and thus it can be appreciated thatthe specific structural and functional details disclosed herein may berepresentative and do not necessarily limit the scope of theembodiments, the scope of which is defined solely by the appendedclaims.

Reference throughout the specification to “various embodiments,” “someembodiments,” “one embodiment,” “an embodiment,” “an exemplaryembodiment,” or the like, means that a particular feature, structure, orcharacteristic described in connection with the embodiment is includedin at least one embodiment. Thus, appearances of the phrases “in variousembodiments,” “in some embodiments,” “in one embodiment,” “in anembodiment,” “in an exemplary embodiment,” or the like, in placesthroughout the specification are not necessarily all referring to thesame embodiment. Furthermore, the particular features, structures, orcharacteristics may be combined in any suitable manner in one or moreembodiments. Thus, the particular features, structures, orcharacteristics illustrated or described in connection with oneembodiment may be combined, in whole or in part, with the featuresstructures, or characteristics of one or more other embodiments withoutlimitation given that such combination is not illogical ornon-functional.

It will be appreciated that the terms “proximal” and “distal” may beused throughout the specification with reference to a clinicianmanipulating one end of an instrument used to treat a patient. The term“proximal” refers to the portion of the instrument closest to theclinician and the term “distal” refers to the portion located furthestfrom the clinician. It will be further appreciated that for concisenessand clarity, spatial terms such as “vertical,” “horizontal,” “up,” and“down” may be used herein with respect to the illustrated embodiments.However, surgical instruments may be used in many orientations andpositions, and these terms are not intended to be limiting and absolute.

Referring now to the drawings wherein like reference numerals are usedto identify identical or similar components in the various views, FIG. 1illustrates one exemplary embodiment of an elongate medical device 10that is configured to be deflected in one or more directions. Theelongate medical device 10 may comprise, for example, a diagnosticand/or therapy delivery catheter, an introducer or sheath, or other likedevices. For purposes of illustration and clarity, the description belowwill be with respect to an embodiment wherein the device 10 comprises acatheter (i.e., catheter 10). It will be appreciated, however, thatembodiments wherein the device 10 comprises elongate medical devicesother than a catheter remain within the spirit and scope of the presentdisclosure.

With continued reference to FIG. 1, in an exemplary embodiment, thecatheter 10 is configured to be inserted into a patient's body, and moreparticularly, into the patient's heart. The catheter 10 may include ahandle assembly comprising a main body portion 12 (which may be referredto herein simply as “handle 12”) and a modular handle extension 130, ashaft 14 having a proximal end portion 16 and a distal end portion 18,and one or more sensors 20 mounted in or on the shaft 14. In anexemplary embodiment, the sensor(s) 20 is/are disposed at the distal endportion 18 of the shaft 14. The catheter 10 may further include otherconventional components such as, for example and without limitation, atemperature sensor, additional sensors or electrodes, ablation elements(e.g., ablation tip electrodes for delivering RF ablative energy, highintensity focused ultrasound ablation elements, etc.), and correspondingconductors or leads. Additionally, the shaft 14 may include one or morefluid lumens extending from the distal end portion 18 to the proximalend portion 16 (and, in an embodiment, into and though the handle 12)for the delivery and/or removal of one or more fluids such as, forexample only, irrigation fluids, bodily fluids, and cryogenic ablationfluids.

In an exemplary embodiment, the catheter 10 further comprises one ormore electromechanical connectors 22 configured to be electricallycoupled with, for example, one or more electrical elements, such as thesensor(s) 20, to allow such electrical elements to be coupled withcomponents or subsystems of, for example, an electrophysiology (EP)laboratory system. In an embodiment, the electromechanical connector 22may be electrically coupled with the sensor(s) 20 via one or moreelectrical wires that extend from the sensor(s) through the shaft 14.Components or subsystems to which the electromechanical connector mayprovide connectivity may comprise, for example and without limitation, avisualization, navigation, and/or mapping system, an EP monitoring andrecording system (e.g., for monitoring and/or recordingelectrocardiograms (EGM), cardiac signals, etc.), a tissue contactsensing system, an ablation system, a cardiac stimulation system (i.e.,EP stimulator), and the like.

The catheter 10 can further comprise one or more fluid connectors 134configured to provide the catheter 10, and particularly the shaft 14,with connectivity between the fluid lumen(s) in the shaft 14 andexternal systems. The fluid connector 134 may thus be fluidly coupledwith one or more fluid lumens in the shaft 14 and/or handle 12 and maybe configured for connection with a source or destination of such fluidssuch as, for example only, a gravity feed or pump for irrigation fluids.

In an embodiment, both the electromechanical connector 22 and the fluidconnector 134 can be provided on the proximal end of the handleextension 130. The handle extension 130, in turn, can be coupled withthe handle 12 and secured to the handle 12 by an annular band 132. Theband 132 may also simply be provided for aesthetic purposes to obscurethe junction of the handle 12 and the handle extension 130. Under theband 132, the handle extension 130 and handle 12 can be coupled in anynumber of ways known in the art, such as, for example, by press fit orinterference coupling techniques, by complementary interlocking membersdisposed on the handle 12 and handle extension 130, by conventionalfasteners or adhesives, or any other techniques known in the art.

The handle extension 130 may be provided for the purpose of expandingthe number of connectors on the proximal end of a medical device handlewithout a complete redesign of the handle. Accordingly, the handleextension 130 may be altered to accommodate more, fewer, and/ordifferent connectors. For example, an embodiment of the handle extension130 may include a port for a second electromechanical connector forconnection to, for example only, a second visualization, navigation,and/or mapping system. Embodiments of the handle extension 130 are shownin greater detail in FIGS. 9A-9G and are discussed below.

The handle 12 is disposed at the proximal end portion 16 of the shaft14. The handle 12 provides a location for the clinician to hold thecatheter 10 and, as will be described in greater detail below, mayfurther provide means for steering or guiding the shaft 14 within thebody of a patient.

As illustrated in FIGS. 1 and 2, the handle 12 comprises a housing 24.The housing 24 may be of a unitary construction or may be constructed ofa plurality of pieces that are configured to be assembled together. Forexample, and as illustrated in FIG. 2, the housing 24 may comprise afirst or bottom piece 26 and a second or top piece 28. In such anembodiment, the first and second pieces 26, 28 of the housing 24 may becoupled together in any number of ways known in the art, such as, forexample, by press fit or interference coupling techniques, bycomplementary interlocking members disposed on each piece 26, 28 of thehousing 24, by conventional fasteners or adhesives, or any othertechniques known in the art.

Whether the housing 24 is formed of one or multiple pieces, the housing24 comprises an inner surface 30 that defines a cavity 32 in the housing24 that, as will be described below, is configured to house and/orreceive various components of the catheter 10 (e.g., theelectromechanical connector 22, the handle extension 130, variouscomponents of a deflection mechanism that will be described below,etc.). In an exemplary embodiment, and for purposes that will bedescribed in greater detail below, the housing 24 further includes apost 34 protruding from the inner surface 30 and into the cavity 32. Forpurposes that will also be described more fully below, the housing 24may further comprise a pair of guide walls 36 ₁, 36 ₂ extending orprotruding from the inner surface 30 of the housing 24 and into thecavity 32. In such an embodiment, and as shown in FIGS. 3A and 3B, theguide walls 36 ₁, 36 ₂ are located between the proximal end portion 16of the shaft 14 and the post 34. In any event, the handle 12 may beformed of conventional materials such as various types of plastics thatare well known in the art.

Referring to FIGS. 1 and 2, the handle 12 may also, in an embodiment,comprise an extension coupling portion 152 (FIG. 2). The couplingportion 152 can be configured to receive a portion of the handleextension 130 (FIG. 1). In an embodiment, the coupling portion 152 caninclude one or more features, such as an annular protrusion 154, forengaging a portion of the handle extension 130. The coupling portion 152may be a converted connector port—i.e., without the handle extension130, the coupling portion 152 could be used as a connector port for, forexample only, an electromechanical connector. As a result, the couplingportion 152 may have substantially the same dimensions as a connectorport on an embodiment of the handle extension 130.

The shaft 14 of the catheter 10 is an elongate, tubular, flexible memberconfigured for movement within the body of the patient. The shaft 14supports, for example and without limitation, sensors and/or electrodesmounted thereon, such as, for example, the sensor(s) 20, associatedconductors, and possibly additional electronics used for signalprocessing and conditioning. The shaft 14 may also permit transport,delivery, and/or removal of fluids (including irrigation fluids,cryogenic ablation fluids, and bodily fluids), medicines, and/orsurgical tools or instruments. The shaft 14 may be made fromconventional materials such as polyurethane, and may define one or morelumens configured to house and/or transport electrical conductors,fluids, activation or steering wires, or surgical tools. In anembodiment wherein the catheter 10 is a diagnostic and/or therapeuticcatheter, the shaft 14 may be introduced into a blood vessel or otherstructure within the body of a patient through a conventional introduceror sheath. As will be described in greater detail below, the shaft 14may then be steered or guided through the body to a desired location,such as the heart.

The sensor(s) 20 mounted in or on the shaft 14 of the catheter 10 may beprovided for a variety of diagnostic and therapeutic purposes including,for example and without limitation, electrophysiological studies,pacing, cardiac mapping, and ablation. In an exemplary embodiment, oneor more of the sensors 20 are provided to perform a location or positionsensing function. More particularly, and as will be described in greaterdetail below, one or more of the sensors 20 are configured to be apositioning sensor that provides information relating to the location(position and orientation, or “P&O”) of the catheter 10, and the distalend portion 18 of the shaft 14 thereof, in particular, at certain pointsin time. Accordingly, in such an embodiment, as the catheter 10 is movedalong a surface of a structure of interest of the heart and/or about theinterior of the structure, the sensor(s) 20 can be used to collectlocation data points that correspond to the surface of, and/or otherlocations within, the structure of interest. These location data pointscan then be used for a number of purposes such as, for example andwithout limitation, the construction of surface models of the structureof interest.

With reference to FIGS. 1 and 2, the electromechanical connector 22provides electrical and mechanical connection(s) for, among otherthings, the leads (i.e., electrical wires) of the sensor(s) 20 of thecatheter 10, as well as wires or cables extending between the catheter10 and other components of, for example, an EP laboratory system. In anexemplary embodiment, the connector 22 can be disposed within the handleassembly of the catheter 10, and within the housing 24 thereof, inparticular. For example, the connector 22 may be disposed within thecavity 32, and therefore, between the first and second pieces 26, 28 ofthe housing 24. Alternatively, and as illustrated in FIG. 2, theconnector 22 may be disposed within an interior defined by upper andlower pieces 38, 40 of the handle extension 130. In another exemplaryembodiment, rather than being disposed within or as part of the handle12 or handle extension 130, the connector 22 may be disposed apart fromthe handle 12, such as, for example, at the end of a pigtail (not shown)extending from the handle 12 of the catheter 10.

In addition to the components described above, in an exemplaryembodiment, the catheter 10 further comprises a deflection mechanism 42associated with the handle 12 of the catheter 10, and a pull assembly 44(best shown in FIGS. 7A and 7B) disposed at or in the distal end portion18 of the shaft 14 of the catheter 10. As will be described more fullybelow, the combination of the deflection mechanism 42 and the pullassembly 44 provides a means by which a user or physician can effectmovement (e.g., deflection) of the distal end portion 18 of the shaft 14in one or more directions, and therefore, allows the physician to steerthe catheter 10.

With reference to FIGS. 2-3B, in an exemplary embodiment, the deflectionmechanism 42 comprises, at least in part, an actuator 46 comprising arotatable body 48 and one or more activation or steering wires 50. Forpurposes of clarity and illustration, the description below will belimited to an embodiment wherein the deflection mechanism 42 comprisesfirst and second activation wires 50 (i.e., first activation wire 50 ₁and second activation wire 50 ₂). It will be appreciated, however, thatin other exemplary embodiments, the deflection mechanism 42 may comprisemore or less than two activation wires, and therefore, such embodimentsremain within the spirit and scope of the present disclosure.

In the embodiment illustrated in FIGS. 2-3B, and in general terms, therotatable actuator body 48, which may be constructed of, for example,molded plastic, comprises a first outer wall 52, a second outer wall 54that is substantially parallel to the first outer wall 52, and a thirdouter wall 56 that is transverse to and disposed between the first andsecond outer walls 52, 54. The actuator body 48 further comprises afirst portion 58 having a slot 60 (best shown in FIG. 2) formed thereinand a second portion 62 having a channel 64 disposed therein or thereon(best shown in FIGS. 3A and 3B). In an exemplary embodiment, and as willbe described more fully below, the first portion 58 comprises a portionof the third outer wall 56 of the actuator body 48 and the secondportion 62 comprises an inner surface of one of the first and secondouter walls 52, 54 of the actuator body 48. Further, in an exemplaryembodiment, the first and second portions 58, 62 of the body 48 aredisposed at opposite ends of the body 48. As illustrated in FIGS. 3A and3B, when the deflection mechanism 42 is assembled, the activation wires50 ₁, 50 ₂ extend from the channel 64 and out of the rotatable body 48through the slot 60.

More particularly, each of the activation wires 50 ₁, 50 ₂ has aproximal end 66 and a distal end 68 (best shown in FIGS. 7A and 7B). Inan exemplary embodiment, the deflection mechanism 42 further comprises apair of anchors or wire locks 70. As illustrated, for example, in FIGS.3A and 3B, each of the wire locks 70 is attached to the proximal end 66of a respective activation wire 50 (i.e., a first wire lock 70 ₁ isattached to the proximal end 66 of the first activation wire 50 ₁, and asecond wire lock 70 ₂ is attached to the proximal end 66 of the secondactivation wire 50 ₂). The wire locks 70 may be attached to the proximalends 66 of the activation wires 50 in any number of ways. In oneembodiment that is provided for exemplary purposes only and is not meantto be limiting in nature, each wire lock 70 is soldered onto theproximal end 66 of a respective activation wire 50. More particularly,in an embodiment such as that illustrated in FIGS. 8A and 8B, each wirelock 70 comprises a bore 71 therein within which the proximal end 66 ofa corresponding activation wire 50 may be inserted and then soldered inplace. It will be appreciated, however, that any number of attachmenttechniques that are well known in the art may be used instead of asoldering technique to attach the wire locks 70 to the proximal ends 66of the activation wires 50, and such other techniques remain within thespirit and scope of the present disclosure.

As will be described in greater detail below, while the proximal ends 66of the activation wires 50 are disposed within the actuator body 48 whenthe actuator 46 is assembled, the distal ends 68 of the activation wires50 ₁, 50 ₂ are coupled or attached to, for example, the pull assembly 44disposed within the shaft 14 of the catheter 10 (best shown in FIGS. 7Aand 7B).

With continued reference to FIGS. 3A and 3B, in an exemplary embodiment,the wire locks 70 ₁, 70 ₂ are disposed within the channel 64 of theactuator body 48 and are configured, in certain instances, to ride(e.g., slide or glide) therein as the actuator body 48 is rotated.Because the activation wires 50 ₁, 50 ₂ are attached to the wire locks70 ₁, 70 ₂, and the wire locks 70 ₁, 70 ₂ are disposed within thechannel 64, the activation wires 50 ₁, 50 ₂ extend from the channel 64and out of the actuator body 48 through the slot 60 thereof.

More particularly, and with reference to FIGS. 3A-6, in one exemplaryembodiment, the actuator body 48 comprises a base member 72 and a covermember 74. As best shown in FIGS. 4 and 6, the base member 72 comprisesa first face 76, second face 78, and a transverse wall 80 disposedbetween and substantially perpendicular to the first and second faces76, 78. In an exemplary embodiment, the transverse wall 80 of the basemember 72 comprises the third outer wall 56 of the actuator body 48, anda portion of the transverse wall 80 further comprises the first portion58 of the actuator body 48 having the slot 60 disposed therein. In suchan embodiment, the first face 76 of the base member 72 may comprise thesecond portion 62 of the actuator body 48 that comprises the channel 64disposed therein or thereon. As such, the first face 76 may comprise aninner surface of the first outer wall 52 of the actuator body 48, whilethe second face 78 may comprise an outer surface of the first outer wall52.

Similar to the base member 72, in an exemplary embodiment such as thatillustrated in FIGS. 3A, 3B, and 6, the cover member 74 of the actuatorbody 48 comprises a first face 82, a second face 84, and a transversewall 86 disposed between and substantially perpendicular to the firstand second faces 82, 84. The cover member 74, is adapted to overlie thebase member 72, and the first face 82 of the cover member 74 is adaptedto be engaged with the first face 76 of the base member 72. As such, inan exemplary embodiment, the first face 82 of the cover member 74comprises an inner surface of the second outer wall 54 of the actuatorbody 48, while the second face 84 comprises an outer surface of thesecond outer wall 54. As will be described below, the cover member 74 isoperative to retain at least the wire locks 70 ₁, 70 ₂ within thechannel 64.

With reference to FIGS. 4 and 5, the base member 72 of the actuator body48 is illustrated. The base member 72 comprises a first end 88 and asecond end 90 opposite the first end 88. In an exemplary embodiment, thechannel 64 is disposed at the first end 88 of the base member 72, whilethe slot 60 is disposed at the second end 90. Further, in an exemplaryembodiment, the channel 64 comprises a curved channel. In such anembodiment, and in an instance such as that illustrated in FIGS. 4 and 5wherein the transverse surface 80 comprises an annular surface, thechannel 64 may have a degree of curvature that is substantially the sameas that of the transverse surface 80 of the base member 72.

In any event, and irrespective of whether the channel 64 is curved, thedegree of curvature, or where it is located, in an exemplary embodimentthe channel 64 comprises a substantially u- or v-shaped channel defined,at least in part, by first and second side walls 92, 94, and first andsecond end walls 96, 98. Each of the first and second end walls 96, 98are disposed between the first and second end walls 92, 94 at oppositeends of the channel 64.

In an exemplary embodiment, at least one of the end walls 96, 98 have anopening 100 disposed therein. In the embodiment illustrated in FIGS. 4and 5, each of the end walls 96, 98 have an opening 100 disposed therein(i.e., the end wall 96 has an opening 100 ₁ disposed therein, while theend wall 98 has an opening 100 ₂ disposed therein). The openings 100 ₁,100 ₂ are provided to allow for the extension of the activation wires 50₁, 50 ₂ out from the channel 64 within which the wire locks 70 ₁, 70 ₂,and therefore, the proximal ends 66 of the activation wires 50, aredisposed. The openings 100 ₁, 100 ₂ may take any number of forms. Forexample, one or both of the openings 100 ₁, 100 ₂ may comprise a v- oru-shaped notch formed in the respective end walls 96, 98. In anotherexemplary embodiment, however, one or both of the openings 100 ₁, 100 ₂may comprise a hole or another like aperture in the respective sideswalls 96, 98. Accordingly, those of ordinary skill in the art willappreciate that the openings 100 ₁, 100 ₂ may take any number of forms,each of which remains within the spirit and scope of the presentdisclosure. Regardless of the particular form of the openings 100 ₁, 100₂, the openings 100 ₁, 100 ₂ have a size (e.g., diameter) that issmaller than that of the wire locks 70 ₁, 70 ₂ so as to retain the wirelocks 70 ₁, 70 ₂ within the channel 64, thereby preventing the wirelocks 70 ₁, 70 ₂ from exiting the channel 64 through the openings 100 ₁,100 ₂.

With continued reference to FIG. 5, in addition to the channel 64, in anexemplary embodiment the second portion 62 of the actuator body 48,which in the illustrated embodiment comprises at least a portion of thefirst face 76 of the base member 72, further comprises one or morepassageways 102 disposed therein or thereon extending from the slot 60in the first portion 58 (e.g., the transverse surface 80 of the basemember 72) to the opening(s) 100 in the channel 64. In an embodimentwherein the deflection mechanism 42 comprises a pair of activation wires50 ₁, 50 ₂, first and second passageways 102 ₁, 102 ₂ are formed in oron the first face 76 of the base member 72. In such an embodiment, thefirst passageway 102 ₁ extends from the slot 60 to the opening 100 ₁ inthe first end wall 96 of the channel 64, and the second passageway 102 ₂extends from the slot 60 to the opening 100 ₂ in the second end wall 98.In an embodiment such as that illustrated in FIG. 5, the first andsecond passageways 102 ₁, 102 ₂ comprise first and second portions of alarger passageway or groove disposed in or on the first face 76 of thebase member 72. Alternatively, the first and second passageways 102 ₁,102 ₂ may be separate and distinct from each other (i.e., do notcomprise portions of a single larger groove or passageway).

As with the channel 64, in an exemplary embodiment, the passageways 102may have a curved shape. In such an embodiment, and in an instancewherein the transverse surface 80 comprises an annular surface, thepassageways 102 may have a degree of curvature that is substantially thesame as the degree of curvature of the transverse surface 80 of the basemember 72. Further, and as with the channel 64 and openings 100described above, in an exemplary embodiment, the passageways 102 ₁, 102₂ may comprise substantially u- or v-shaped passageways.

In an exemplary embodiment, each of the passageways 102 ₁, 102 ₂ has aconstant width along the length of the passageways 102 ₁, 102 ₂.Alternatively, and as best illustrated in FIG. 5, different portions ofthe passageways 102 ₁, 102 ₂ may have different widths. For example, inthe illustrated embodiment, each of the passageways 102 ₁, 102 ₂ has afirst portion 103 proximate the slot 60, and a second portion 104 thatis in closer proximity to the openings 100 ₁, 100 ₂, respectively, thanthe first portion 103. In an exemplary embodiment, the first portion 103has a width that is less than the width of the second portion 104. Assuch, each passageway 102 ₁, 102 ₂ has a shoulder 105 disposed thereinat the transition between the first and second portions 103, 104.Further, in an exemplary embodiment such as that illustrated in FIG. 5,the first portion 103 defines a longitudinal centerline 106 that isoffset from a longitudinal centerline 107 defined by the second portion104. As a result, and as illustrated in FIG. 5, while in an exemplaryembodiment the longitudinal centerlines of the openings 100 ₁, 100 ₂ arealigned with both the longitudinal centerline of the channel 64 and therespective longitudinal centerlines 107 of the second portions 104 ofthe passageways 102 ₁, 102 ₂, the respective centerlines 107 of thesecond portions 104 of the passageways 102 ₁, 102 ₂ are offset from therespective centerlines 106 of the first portions 103. More particularly,in an exemplary embodiment, the centerlines 106 of the first portions103 are offset from the centerlines 107 of the second portions 104 in adirection toward the third outer wall 56/transverse wall 80. One purposeof employing passageways 102 having varying widths and being arranged asdescribed above is to allow for a greater degree of deflection ascompared to other known deflection mechanisms wherein the centerlines ofthe openings in the channel are aligned with the centerline of thechannel 64 and the centerlines of the entire passageways 102 that has aconstant width along its length.

In the illustrated embodiment, each of the passageways 102 ₁, 102 ₂ areconfigured to have a respective one of the activation wires 50 ₁, 50 ₂extend therethrough. More particularly, and with reference to FIGS. 3A,3B, and 5, the first activation wire 50 ₁ extends from the first wirelock 70 ₁ disposed in the channel 64, through the opening 100 ₁ in theend wall 96 of the channel 64, through the first passageway 102 ₁, andout of the actuator body 48 through the slot 60 in the transversesurface 80 of the base member 72. Similarly, the second activation wire50 ₂ extends from the second wire lock 70 ₂ also disposed in the channel64, through the opening 100 ₂ in the end wall 98 of the channel 64,through the second passageway 102 ₂, and out through the slot 60.

As briefly described above, in an embodiment wherein the actuator body48 is of a two-piece construction comprising the base member 72 and thecover member 74, the cover member 74 is operative to engage the firstface 76 of the base member 72 and to retain the wire locks 70 ₁, 70 ₂ inthe channel 64. More particularly, FIG. 6 depicts a cross-sectional viewof a portion of the actuator body 48 illustrating the cover member 74overlying the base member 72, with the first face 82 of the cover member74 being engaged with the first face 76 of the base member 72 to retainthe wire locks 70 ₁, 70 ₂ in the channel 64.

Similarly, in an exemplary embodiment wherein the end walls 96, 98 ofthe channel 64 have respective openings 100 ₁, 100 ₂, therein, and/orthe activation wires 50 ₁, 50 ₂ extend through the respectivepassageways 102 ₁, 102 ₂, the cover portion 74 is operative to retainthe activation wires 50 ₁, 50 ₂ in the openings 100 ₁, 100 ₂, and/or thepassageways 102 ₁, 102 ₂ in the same manner as that described above withrespect to the wire locks 70. Finally, in an exemplary embodiment, thecover member 74 may be still further operative to retain the activationwires 50 ₁, 50 ₂ in the slot 60 of the actuator body 48 in the samemanner as that described above.

Accordingly, once the wire locks 70 and the activation wires 50 areassembled with the base member 72, in an exemplary embodiment, the basemember 72 and the cover member 74 may be coupled or affixed togetherusing techniques that are well known in the art. For example, the baseand cover members 72, 74 may be coupled together using press fit orinterference coupling techniques, by complementary interlocking membersdisposed on each of the base and cover members 72, 74, by conventionalfasteners or adhesives, or any other techniques known in the art.Alternatively, the base and cover members 72, 74 may not be coupled oraffixed together at all, but rather may be held or compressed togetherby virtue of the particular construction of the handle 12 and the naturein which it is assembled (e.g., the when the handle 12 is fullyassembled, the base and cover members 72, 74 are subjected to acompression force that is sufficient to hold the base and cover portions72, 74 together as if they were otherwise coupled or affixed together).

Whether the second portion 58 of the actuator body 48, which, again, inthe illustrated embodiment, comprises the base member 72 of the actuatorbody 48, includes only the channel 64 or both the channel 64 and thepassageways 102 ₁, 102 ₂, each the end walls 96, 98 of the channel 64are configured and operative to engage and apply a force onto arespective one of the wire locks 70 ₁, 70 ₂ when the actuator body 48 isrotated in a respective direction.

More particularly, and as illustrated in FIG. 3A, when the actuator body48 is in a neutral position (i.e., the shaft 14 of the catheter 10 is ina neutral or non-deflected state), the wire locks 70 ₁, 70 ₂ disposed inthe channel 64 are in contact with the end walls 96, 98 of the channel64, respectively. In an exemplary embodiment such as that illustrated inFIG. 3B, when the actuator body 48 is rotated in a first direction 108(e.g., in a clockwise direction), the first end wall 96 of the channel64 is operative to engage and apply a force onto the first wire lock 70₁. The force applied onto the first wire lock 70 ₁ by the end wall 96 asthe actuator body 48 is rotated clockwise causes tension to be appliedto the first activation wire 50 ₁ (i.e., the first activation wire 50 ₁is caused to be “pulled”). Conversely, as the actuator body 48 isrotated in the first direction 108, the second end wall 98 of thechannel 64 moves away from the second wire lock 70 ₂ and therefore, noforce is applied onto the second wire lock 70 ₂. Rather, as illustratedin FIG. 3B, the second wire lock 70 ₂ rides within the channel 64 as theactuator body 48 rotates in the first direction 108, thereby preventingthe second activation wire 50 ₂ from being either “pushed” or “pulled”.

Similarly, the second end wall 98 of the channel 64 is operative toengage and apply a force onto the second wire lock 70 ₂ disposed in thechannel 64 when the actuator body 48 is rotated in a second direction109 opposite the first direction 108 (e.g., in a counterclockwisedirection). As with the first activation wire 50 ₁ described above, theforce applied onto the second wire lock 70 ₂ by the end wall 98 as theactuator body 48 is rotated in the second direction 109 causes tensionto be applied to the second activation wire 50 ₂ (i.e., the secondactivation wire 50 ₂ is caused to be “pulled”). Conversely, as theactuator body 48 is rotated in the second direction 109, the first endwall 96 of the channel 64 moves away from the first wire lock 70 ₁, andtherefore, no force is applied onto the first wire lock 70 ₁. Rather,the first wire lock 70 ₁ rides within the channel 64 as the actuatorbody 48 rotates in the second direction 109, thereby preventing thefirst activation wire 50 ₁ from being either “pushed” or “pulled”.

In order to facilitate the riding of the wire locks 70 within thechannel 64, in an exemplary embodiment such as that illustrated in FIGS.8A and 8B, the wire locks 70 have a substantially spherical shape. Itwill be appreciated, however, that the present disclosure is not meantto be limited to such an embodiment, but rather in other exemplaryembodiments that remain within the spirit and scope of the presentdisclosure, the wire locks 70 may have any number of shapes and suchembodiments remain within the spirit and scope of the presentdisclosure.

One advantage of the arrangement described above wherein the wire locks70 are configured to ride within the channel 64 is that bending orbuckling and weakening of the activation wires resulting from thepushing of the activation wires in a direction toward the catheter shaft14 is prevented. More particularly, one drawback of certain conventionaldeflection mechanisms such as those described elsewhere herein has beenwith respect to pushing forces being applied to the activation wiresthat are not being selectively tensioned. More particularly, in certainconventional deflection mechanisms, the actuator thereof comprises oneor more posts that are each configured to be coupled to the proximal endof a respective activation wire. For example, in an instance wherein thedeflection mechanism comprises a pair of activation wires, the actuatormay include a pair of posts, each one of which has a respective one ofthe activation wires coupled thereto. In such an instance, as theactuator is manipulated to deflect the shaft in a desired direction, apulling force is applied onto one of the activation wires, therebycausing tension to be applied to that activation wire. Meanwhile, theother activation wire that is not subjected to the pulling force may becaused to be pushed in the opposite direction of the pulling force, andinto, for example, the housing of the handle assembly. As a result ofthis pushing force, the activation wire being pushed may bend or buckle,thereby causing the activation wire to weaken and potentially fail(e.g., the activation wire may eventually snap).

In the present disclosure, because the wire locks 70 are configured toride within the channel 64 as tension is applied to one of theactivation wires 50 (i.e., the activation wire is “pulled” in thedirection away from the catheter shaft 14), the wire lock 70corresponding to the non-tensioned activation wire 50 is allowed to ridewithin the channel 64, and therefore, the non-tensioned activation wire50 is not caused to be pushed, and thus, bending or buckling andweakening of that activation wire 50 resulting from the pushing of theactivation wire 50 is prevented.

As briefly described above, and as illustrated in, for example, FIGS. 1,3A, and 3B, the deflection mechanism 42 is associated with the handle 12of the catheter 10. More particularly, in an exemplary embodiment, theactuator body 48 of the deflection mechanism 42 is rotatably mountedwithin a portion of the cavity 32 of the handle housing 24 and, in theillustrated embodiment, is disposed between the first and second pieces26, 28 of the housing 24. As illustrated in FIG. 2, in an exemplaryembodiment, the actuator body 48 has an aperture 110 extendingtherethrough configured to receive the post 34 of the handle housing 24.When the actuator body 48 is assembled with the post 34, the actuatorbody 48 is configured to rotate about the post 34.

In the illustrated embodiment wherein the catheter handle 12 comprisesfirst and second pieces 26, 28, once the actuator body 48 is positionedwithin the cavity 32 and onto the post 34 of the housing 24, the housing24 may be assembled together. More particularly, in an exemplaryembodiment, the second piece 28 of the housing 24 may be aligned withthe first piece 26 thereof and press fit together. As illustrated inFIG. 2, the handle 12 may further comprise an O-ring 111. The O-ring 111may be disposed between the actuator body 48 and the first outer wall 52thereof, in particular (which in one embodiment comprises the coverportion 74), and the inner surface of the housing 24 (which in oneembodiment comprises the inner surface of the second piece 28 of thehousing 24). As illustrated in FIGS. 1 and 2, in order to allow for aphysician to manipulate or rotate the actuator body 48, the housing 24of the handle 12 may further comprise one or more slots 112 thereinthrough which the actuator body 48 extends and within which the actuatorbody 48 may rotate. In the embodiment illustrated in FIGS. 1 and 2, thehousing 24 comprises a pair of slots 112 ₁, 112 ₂ disposed ondiametrically opposite sides of the housing 24.

Further, in an embodiment such as that illustrated in, for example,FIGS. 1 and 2, while the actuator body 48 may rotate within the slot(s)112 of the handle housing 24, it may comprise one or more protrusions114 extending outwardly therefrom (e.g., from the third outer wall56/transverse wall 80) that is/are configured to limit the extent towhich the actuator body 48 may be rotated. More particularly, in theillustrated embodiment, which includes a pair of protrusions 114 ₁, 114₂ disposed on diametrically opposite sides of the actuator body 48, theprotrusions 114 ₁, 114 ₂ extend outwardly a suitable distance such thatwhen the protrusions 114 ₁, 114 ₂ reach an end of the respective slots112 ₁, 112 ₂, they make contact with the housing 24, which therebyprevents the further rotation of the actuator body 48 in that particulardirection.

In addition to limiting the rotation of the actuator body 48, theprotrusions 114 ₁, 114 ₂ may further provide a means by which aphysician using the catheter 10 can determine when the shaft 14 is in aneutral or non-deflected state. For example, when the protrusions 114 ₁,114 ₂ are centered within the slots 112, the physician can tell that theshaft 14 is in a non-deflected state.

It will be appreciated that while the illustrated embodiment comprises apair of protrusions 114, the present disclosure is not meant to be solimited. Rather, in other exemplary embodiments that remain within thespirit and scope of the present disclosure, the body 48 may comprise asingle protrusion or more than two protrusions that serve the samefunction and purpose described above.

As briefly described above, the distal ends 68 of the activation wires50 ₁, 50 ₂ of the deflection mechanism 42 are attached to the pullassembly 44 disposed within the shaft 14 of the catheter 10. Theactivation wires 50 ₁, 50 ₂ may be attached to the pull assembly 44 inan number of ways that are well known in the art, such as, for exampleand without limitation, by soldering or otherwise adhering thecomponents together with a suitable adhesive. From the pull assembly 44,the activation wires 50 ₁, 50 ₂ extend through the shaft 14 to theproximal end portion 16 of the shaft 14. In an exemplary embodiment, theactivation wires are disposed within one or more lumens (not shown) inthe shaft 14. In any instance, and as illustrated in FIGS. 3A and 3B,the activation wires 50 ₁, 50 ₂ further extend from the proximal endportion 16 of the shaft 14 through the housing 24 of the handle 12, andthe cavity 32 thereof, in particular, and into the slot 60 of theactuator body 48. As briefly described above, in an exemplaryembodiment, the handle housing 24 further comprise a pair of guide walls36 ₁, 36 ₂ extending or protruding from the inner surface 30 of thehousing 24 (and, in an exemplary embodiment, the first or bottom piece26 thereof, in particular) and into the cavity 32. Each of the guidewalls 36 ₁, 36 ₂ is configured to act as a guide for a respective one ofthe activation wires 50 ₁, 50 ₂ as the wires 50 ₁, 50 ₂ extend from theproximal end portion 16 of the shaft 14 and into the slot 60 of theactuator body 48.

In an exemplary embodiment, the handle 12 may further comprise means bywhich the ability to rotate the actuator body 48 may be controlled. Forexample, in the embodiment illustrated in FIG. 2, the handle 12 mayinclude a tension knob 116 that is operative to increase or decrease thecompression force applied to the actuator 46, and therefore, increase ordecrease the ability to rotate the actuator body 48. One advantage ofsuch functionality is that once a physician has deflected the shaft 14 adesired amount, the physician may maintain the deflection by adjustingthe tension knob 116 to limit the ability to rotate the actuator body 48in either direction.

In an exemplary embodiment such as that illustrated in, for example,FIG. 2, in addition to the tension knob 116, the handle 12 may furthercomprise a screw 118 that is configured to be mated with a threadedrecess in the tension knob 116. In such an embodiment, the post 34 ofthe housing 24 may comprise a through-going bore 120, which may comprisea threaded bore, extending through the length of the post 34 and theouter surface of the housing 24 (e.g., through the outer surface of thefirst or bottom piece 26 of the housing 24). In such an embodiment, thehousing 24 further comprises an aperture 122 that is coaxially alignedwith the post 34, and the bore 120 thereof, in particular. In theillustrated embodiment, the aperture 122 is disposed in the second ortop piece 28 of the housing 24. When the screw 118 and the tension knob116 are assembled together, the shaft of the screw 118 extends throughthe bore 120, O-ring 111 (if applicable), and the aperture 122 in thehousing 24. The tension knob 116 is mated with the end of the shaft ofthe screw 118, such as, for example, by threading the tension knob 116onto the threaded shaft of the screw 118. Once assembled with the screw118, the tension knob 116 can be adjusted to increase or decrease thecompression force that is applied between the pieces 26, 28 of thehousing 24, and the various components disposed therebetween. Forexample, the tightening of the tension knob 116 may result in anincrease in the applied compression force, while the loosening of thetension knob 116 may result in a decrease in the compression force. Themore compression force that is applied, the more the ability to rotatethe actuator body 48 is limited.

As briefly described above, when assembled with the handle 12 and othercomponents of the catheter 10, the deflection mechanism 42, and theactuator 46 thereof, in particular, is configured to be selectivelymanipulated to cause the distal end portion 18 of the shaft 14 todeflect in one or more directions. More particularly, the manipulation(e.g., rotation) of the body 48 of the actuator 46 causes the selectivetensioning of the activation wires 50 ₁, 50 ₂, thereby effectingmovement of the pull assembly 44 (e.g., a pull ring), and thus, theshaft 14.

For example, in the embodiment illustrated in FIGS. 7A and 7B, when theactuator body 48 is rotated in a clockwise direction, the activationwire 50 ₁ is pulled in a direction that is away from the shaft 14 of thecatheter 10, thereby applying tension to the activation wire 50 ₁. Thetensioning of the activation wire 50 ₁ causes the pull assembly 44 to bepulled, resulting in the deflection of the shaft 14 in a firstdirection. Similarly, when the actuator body 48 is rotated in acounterclockwise direction, the activation wire 50 ₂ is pulled in adirection that is away from the shaft 14 of the catheter 10, therebyapplying tension to the activation wire 50 ₂. The tensioning of theactivation wire 50 ₂ causes the pull assembly 44 to be pulled, resultingin the deflection of the shaft 14 in a second direction that is oppositethe first direction.

Accordingly, the arrangement or configuration of the deflectionmechanism 42 described herein above permits the manipulation of theactuator 46 thereof to allow a physician to steer and navigate thecatheter 10 through the body of patient, while at the same timepreventing the pushing of the activation wires 50 toward the shaft 14 ofthe catheter 10 and into a portion of the cavity 32 of the handlehousing 24 that is forward of the actuator 46. As such, bending orbuckling and weakening of the activation wires 50 resulting from suchpushing of the activation wires 50 is prevented.

FIGS. 9A-9C illustrate an embodiment of the handle extension 130 shownin FIGS. 1-2. The handle extension 130 can include a first connectorport 140 and a second connector port 142 on a distal end of the handleextension, and a handle coupling portion 144 on a proximal end of thehandle extension. The connector ports can be configured to accommodatedifferent types of connectors, as noted above. In the embodiment shown,the first connector port 140 may be provided for a fluid connector(e.g., fluid connector 134, see FIG. 2), and the second connector port142 for an electromechanical connector (e.g., electromechanicalconnector 22, see FIG. 2). The connector ports 140, 142 can beconfigured in size and shape to provide access to the connectors. Forexample, in an embodiment, the connector ports may hold and/or securethe connectors such that one or both of the connectors extend to theexterior of the handle (e.g., as shown in FIG. 2). In an alternateembodiment, one or both of the connectors may be disposed entirelywithin the interior of the handle extension 130 and/or within the handlemain body portion, with the ports 140, 142 acting as passageways throughwhich cabling may be inserted for connection to the connectors. Ofcourse, as noted above, additional and/or alternative connector portsmay be provided for different requirements of a different medicaldevice.

The handle coupling portion 144 may be configured to be secured to themain body portion of a medical device handle. In an embodiment, thehandle coupling portion 144 may be secured to the proximal end of a mainbody portion of a handle (e.g., main body portion 12), as shown inFIG. 1. Alternatively, the handle coupling portion 144 can be secured toa different portion of the main body of a handle. The handle couplingportion 144 and the main body portion of the handle may be coupledtogether in any number of ways known in the art, such as, for example,by press fit or interference coupling techniques, by complementaryinterlocking members disposed on the handle coupling portion 144 and thehandle main body, by conventional fasteners or adhesives, or any othertechniques known in the art. For example, the handle coupling portion144 can include an annular groove 156 for engaging a portion of thehandle 12, such as the annular protrusion 154 of the coupling portion152 of the handle, shown in phantom in FIG. 9C (see also FIG. 2). In anembodiment and as shown in FIGS. 2, 9C, and 9E-9G, for example, thehandle coupling portion 144 may be configured to be inserted into aportion of a handle. The handle coupling portion 144 may be additionallyor alternatively configured to receive a portion of the handle (e.g.,may include an orifice, as illustrated by the lower portion of thecoupling portion 144W in FIG. 9D).

As shown in FIGS. 2 and 9A-9C, the handle extension 130 may, in anembodiment, comprise a two-piece construction with an upper piece 40 anda lower piece 38. Referring now to FIGS. 9A-9C, the upper piece 40 maydefine a first portion of the connector ports 140A, 142A, and a firstportion of the handle coupling portion 144A and the annular groove 156A.The lower piece 38 may similarly define a second portion of theconnector ports 140B, 142B, and a second portion of the handle couplingportion 144B and the annular groove 156B. The upper and lower pieces 40,38 may be coupled together in any number of ways known in the art, suchas, for example, by press fit or interference coupling techniques, bycomplementary interlocking members disposed on each piece 40, 38, byconventional fasteners or adhesives, or any other techniques known inthe art. In an embodiment, the lower piece 38 can comprise a number ofpins 146 configured to be coupled with a number of holes 148 in theupper piece. For visual clarity, not all pins 146 and holes 148 areindicated.

Whether a two-piece or other construction, the handle extension 130 candefine an interior 150 configured to receive one or more connectorscoupled with the a handle main body portion. The connectors can beelectromechanical, fluid, or other connectors known in the art and canbe coupled with the main body portion of the handle directly (i.e.,extending entirely through the interior 150 to mechanically connect withthe handle main body portion) or indirectly (e.g., through electricalwires, a fluid lumen, etc. extending through the interior 150).

In various embodiments, the size and shape of handle extension 130 mayvary and/or the ports 140, 142 may be of a different size and/or anglewith respect to each other or to the handle coupling portion 144 thanthat shown in FIGS. 9A-9C. For example, as shown in FIGS. 9D-9F, ports140, 142 may be provided on the same side of the handle extension (e.g.,on the proximal end), but at differing angles with respect to each otherand to the handle coupling portion and/or at differing lateral positions(e.g., compare ports 140′, 142′ in FIG. 9D (widest angle), ports 140″,142″ in FIG. 9E (wider angle), and 140′″, 142′″ in FIG. 9F (narrowerangle) with ports 140, 142 in FIGS. 9B and 9C (narrowest angle).Further, as illustrated in FIG. 9G, the ports 140″″, 142″″ may bejuxtaposed such that a first port opens to a first side of a handle andanother port opens to an opposing second side of the handle. Inaddition, although the ports 140, 142 are shown on an “end” of thehandle extension 130 in FIGS. 1, 2, and 9A-F and the “sides” of thehandle extension 130 in FIG. 9G, the ports 140, 142 may also be disposedon the “top,” “bottom,” or other portion of the handle extension 130.

Although the handle extension portion embodiments 38′, 38″ 38′″, and38″″ respectively illustrated in FIGS. 9D-9G are diagrammatically shown,it should be understood that one or more interior features substantiallysimilar to the interior features shown on the handle extension portion38 illustrated in FIG. 9C may be included in any embodiment.Furthermore, although only lower pieces 38′, 38″ 38′″, and 38″″ areillustrated in FIGS. 9D-9G, complementary upper pieces for eachembodiment may also be provided.

In an embodiment, the handle extension 130 may be provided as a modulardevice to expand the number of connector ports on an existing catheterhandle. In such an embodiment, the handle coupling portion 144 may beconfigured to occupy (e.g., may be configured for insertion into) one ormore existing connector ports on the handle, and one of the connectorports 140, 142 on the handle extension may replicate a connector port onthe handle. As a result, the dimensions (e.g., shape, diameter) of aconnector port 140, 142 may be substantially the same as the dimensionsof a connector port on the handle with which the handle coupling portion144 is coupled. For example, in the embodiment shown in FIGS. 9A-9G, thesecond connector port 142 may have substantially the same dimensions asa port on a catheter handle with which the handle coupling portion 144is configured to be coupled.

The modularity of the handle extension 130 advantageously can enable anexisting catheter handle to be adapted to new shaft constructions havingdifferent electrical, fluid, and other requirements than a shaft forwhich the existing handle was originally designed without a redesign ofthe entire handle. As a result, a designer and/or manufacturer of ahandle need not design, test, and manufacture an entirely new handle foreach advance in shaft design. Furthermore, a single handle extensiondesign can be used for multiple different handle designs, provided thatthe multiple different handle designs share one or more common featuresallowing for the handle extension to be coupled to the handle.

Although embodiments of this invention have been described above with acertain degree of particularity, those skilled in the art could makenumerous alterations to the disclosed embodiments without departing fromthe spirit or scope of this invention. All directional references (e.g.,upper, lower, upward, downward, left, right, leftward, rightward, top,bottom, above, below, vertical, horizontal, clockwise, andcounterclockwise) are only used for identification purposes to aid thereader's understanding of the present invention, and do not createlimitations, particularly as to the position, orientation, or use of theinvention. Joinder references (e.g., attached, coupled, connected, andthe like) are to be construed broadly and may include intermediatemembers between a connection of elements and relative movement betweenelements. As such, joinder references do not necessarily infer that twoelements are directly connected and in fixed relation to each other. Itis intended that all matter contained in the above description or shownin the accompanying drawings shall be interpreted as illustrative onlyand not limiting. Changes in detail or structure may be made withoutdeparting from the spirit of the invention as defined in the appendedclaims.

Any patent, publication, or other disclosure material, in whole or inpart, that is said to be incorporated by reference herein isincorporated herein only to the extent that the incorporated materialsdoes not conflict with existing definitions, statements, or otherdisclosure material set forth in this disclosure. As such, and to theextent necessary, the disclosure as explicitly set forth hereinsupersedes any conflicting material incorporated herein by reference.Any material, or portion thereof, that is said to be incorporated byreference herein, but which conflicts with existing definitions,statements, or other disclosure material set forth herein will only beincorporated to the extent that no conflict arises between thatincorporated material and the existing disclosure material.

What is claimed is:
 1. A handle assembly for a medical device, comprising: a main body portion configured to be coupled with an elongate medical device shaft comprising at least one of an electrical wire and a fluid lumen, said main body portion comprising: an outer housing defining an interior and having an exterior; and a handle port in said outer housing, said handle port defining a passageway from said exterior of said outer housing to said interior of said outer housing, said handle port configured to provide access to one or more of a fluid connector fluidly coupled with the fluid lumen and an electromechanical connector electrically coupled with the electrical wire; and a handle extension portion comprising: a coupling portion coupled with said handle port; an outer housing defining an interior and having an exterior; and two or more handle extension ports, each of said handle extension ports defining a respective passageway from said exterior of said handle extension portion outer housing to said interior of said handle extension portion outer housing.
 2. The handle assembly of claim 1, wherein a first of said handle extension ports is configured to provide access to one or more of a fluid connector fluidly coupled with the fluid lumen and an electromechanical connector electrically coupled with the electrical wire.
 3. The handle assembly of claim 2, wherein said first handle extension port is configured to provide access to the electromechanical connector, wherein a second of said handle extension ports is configured to provide access to the fluid connector.
 4. The handle assembly of claim 3, wherein said first handle extension port and said second handle extension port are disposed generally on the same side of said extension portion outer housing.
 5. The handle assembly of claim 3, wherein said first handle extension port and said second handle extension port are disposed generally on different sides of said extension portion outer housing.
 6. The handle assembly of claim 5, wherein said first handle extension port and said second handle extension port are disposed generally on opposite sides of said extension portion outer housing.
 7. The handle assembly of claim 3, further comprising an electromechanical connector disposed in said first handle extension port and a fluid connector disposed in said second handle extension port.
 8. The handle assembly of claim 1, wherein said coupling portion comprises an annular groove and said handle port comprises an annular protrusion, wherein said annular groove is configured to receive said annular protrusion.
 9. An elongate medical device, comprising: a shaft comprising a distal end, a proximal end, and at least one of: an electrical wire; and a fluid lumen; and a handle comprising: a main body portion coupled with said shaft proximal end, said main body portion comprising: an outer housing defining an interior and having an exterior; a handle port defining a passageway from said interior to said exterior, said handle port configured to provide access to one or more of a fluid connector fluidly coupled with the fluid lumen and an electromechanical connector electrically coupled with the electrical wire; and a handle extension portion comprising: a coupling portion coupled with said handle port; an outer housing defining an interior and having an exterior; and two or more handle extension ports, each of said handle extension ports defining a respective passageway from said exterior of said handle extension portion outer housing to said interior of said handle extension portion outer housing.
 10. The elongate medical device of claim 9, wherein said handle main body portion outer housing comprises a distal end coupled with said shaft proximal end and a proximal end comprising said handle port.
 11. The elongate medical device of claim 10, wherein a first of said handle extension ports is configured to provide access to one or more of a fluid connector fluidly coupled with said fluid lumen and an electromechanical connector electrically coupled with said electrical wire.
 12. The elongate medical device of claim 11, wherein said handle extension portion outer housing comprises a distal end coupled with said main body portion and a proximal end comprising said two or more handle extension ports.
 13. The elongate medical device of claim 11, wherein said shaft comprises said electrical wire and said fluid lumen, wherein said first handle extension port is configured to provide access to an electromechanical connector electrically coupled with said electrical wire, wherein a second of said handle extension ports is configured to provide access to a fluid connector fluidly coupled with said fluid lumen.
 14. The elongate medical device of claim 13, wherein said first handle extension port and said second handle extension port are disposed generally on the proximal end of said handle extension portion outer housing.
 15. The elongate medical device of claim 11, wherein at least one of said handle extension ports is substantially the same size and shape as said handle port.
 16. The elongate medical device of claim 11, further comprising at least one of: an electromechanical connector electrically coupled to the electrical wire and disposed at least partially in one of said handle extension ports; and a fluid connector fluidly coupled to the fluid lumen and disposed at least partially in one of said handle extension ports.
 17. A handle assembly for a medical device, comprising: a main body portion configured to be coupled with an elongate shaft and to receive one or more of an electrical wire in the shaft and a fluid lumen in the shaft, said main body portion comprising: an outer housing defining an interior and having an exterior; and a handle port defining a passageway from said exterior to said interior, said handle port configured to provide access to one or more of an electromechanical connector electrically coupled to the electrical wire and a fluid connector fluidly coupled to the fluid lumen; and an extension portion, configured to occupy said handle port, said extension portion comprising: an outer housing defining an interior and having an exterior; and two or more extension ports, each defining a respective passageway from said exterior of said extension portion outer housing to said interior of said extension portion outer housing, at least one of said extension ports configured to replicate said handle port.
 18. The handle assembly of claim 17, wherein a first of said extension ports is configured to provide access to an electromechanical connector and a second of said extension ports is configured to provide access to a fluid connector.
 19. The handle assembly of claim 17, wherein said handle extension portion housing comprises a coupling portion comprising an annular groove and said handle port comprises an annular protrusion, wherein said annular groove is configured to receive said annular protrusion. 